Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

430

Participants

Timeline

Start Date

April 9, 2021

Primary Completion Date

August 23, 2023

Study Completion Date

December 31, 2027

Conditions
MyelofibrosisPrimary MyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia Myelofibrosis
Interventions
DRUG

Pelabresib

"Double-blind treatment (pelabresib or matching placebo) will be administered daily for 14 consecutive days followed by a 7-day break, which is considered 1 cycle of treatment (1 cycle = 21 days).~Pelabresib is a small molecule inhibitor of BET proteins with a novel mechanism of action and potential for disease-modifying effects in MF."

DRUG

Ruxolitinib

Ruxolitinib is a JAK inhibitor and a current, approved treatment option for MF.

DRUG

Placebo

Placebo tablets are designed to match pelabresib tablets. Each placebo tablet contains no active pharmaceutical ingredient and is visibly identical to experimental drug in size, shape, and packaging. Placebo dosing follows the same dosing conventions as pelabresib.

Trial Locations (156)

1081

Amsterdam UMC, Amsterdam

1200

Cliniques universitaires Saint-Luc, Brussels

3168

Monash Health, Clayton

3199

Peninsula Private Hospital Clinical Trials Unit, Frankston

4000

Domaine Universitaire du Sart Tilman, Liège

4020

Krankenhaus der Elisabethinen Linz, Linz

4021

Kepler University Hospital, Linz

4101

Icon Cancer Centre, Brisbane

5000

Royal Adelaide Hospital, Adelaide

5020

University Hospital Salzburg, Salzburg

6009

One Clinical Research PTY LTD, Nedlands

7100

Hôpital de Jolimont, La Louvière

7624

: Pecs University, 1st Department of Medicine, Pécs

8039

Erciyes University Faculty of Medicine Hospital, Kayseri

8916

ICO Badalona - Hospital Universitari Germans Trias i Pujol, Badalona

10003

Hospital San Pedro de Alcantara, Cáceres

10029

Icahn School of Medicine at Mount Sinai, New York

10065

Memorial Sloan Kettering Cancer Center, New York

Weill Cornell Medical College- New York Presbyterian Hospital, New York

10128

Hospital Ordine Mauriziano of Turin, Turin

10210

Chulabhorn Hospital, Bangkok

10330

King Chulalongkorn Memorial Hospital, Bangkok

10400

Rajavithi Hospital, Bangkok

10450

Hospital Pulau Pinang, George Town

20246

University Hospital Hamburg-Eppendorf, Hamburg

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo

25123

Regional Hospital Spedali Civili di Brescia, Brescia

26504

University General Hospital of Patras, Rio

28100

University Hospital Maggiore della Carità, Novara

28223

Quirónsalud Madrid University Hospital, Madrid

30008

Morales Meseguer General University Hospital, Murcia

30029

Gard Cancer Institute, Nîmes

32224

Mayo Clinic, Jacksonville

33011

Hospital Universitario Central de Asturias, Oviedo

33612

Moffitt Cancer Center, Tampa

35010

Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria

35033

Chu Pontchaillou - Service Hematologie, Rennes

35128

University Hospital of Padova, Padua

37007

Hospital Universitario de Salamanc, Salamanca

37044

Hôpital Bretonneau, Tours

40002

Srinagarind hospital,Khon Kaen University, Khon Kaen

40138

A.O.U. Policlinico S. Orsola-Malpighi, Bologna

40207

Norton Cancer Institute, St. Matthews Campus, Louisville

41944

Kyungpook National University Hospital, Daegu

42271

Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

45007

University Hospital of Toledo, Toledo

46010

Hospital Clínico Universitario de Valencia, Valencia

46237

Franciscan Health/Indiana blood and Marrow Transplantation, Indianapolis

47500

Sunway Medical Centre, Petaling Jaya

48108

Inje University Haeundae Paik Hospital, Busan

48109

University of Michigan Medical Center, Ann Arbor

49100

Rabin Medical Center - Beilinson Campus,, Petah Tikva

49241

Pusan National University Hospital, Busan

54500

Chru Brabois, Vandœuvre-lès-Nancy

54907

Jeonbuk National University Hospital, Jeonju

62526

Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL, Decatur

63110

Washington University, St Louis

68000

:Hospital Ampang, Ampang

69310

Centre Hospitalier Lyon Sud Secteur 1G, Pierre-Bénite

72000

Centre Hospitalier, Le Mans

77030

MD Anderson Cancer Center, Houston

78229

University of Texas Health Science Center - San Antonio, San Antonio

80054

Amiens South Hospital univerisy - Hopital Sud, Amiens

80100

Hospital Sultanah Aminah, Johor Bahru

84101

Soroka Medical Center, Beersheba

85224

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Chandler

86151

Hämatologisch-Onkologische Praxis Augsburg, Augsburg

88586

Hospital Queen Elizabeth, Kota Kinabalu

89081

Universitätsklinikum Ulm, Ulm

90033

USC/Norris Comprehensive Cancer Center, Los Angeles

90095

UCLA Medical Center, Los Angeles

90110

Songklanagarind Hospital, Songkhla

90127

University Hospital 'Paolo Giaccone' Polyclinic, Palermo

92093

UC San Diego Moores Cancer Center, La Jolla

98104

Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute, Seattle

2210001

Shaarei Zedek, Nahariya

3109601

Rambam Health Corporation, Haifa

3436212

Lady Davis Carmel Medical Center, Haifa

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

9590300

Hadassah University Hospital-Ein Kerem, Jerusalem

60930000

Shamir Medical Center, Be’er Ya‘aqov

35294-3300

University of Alabama at Birmingham, Birmingham

06510

Yale University School of Medicine, New Haven

QLD 4556

USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic, Buderim

A-8036

LKH - Universitätsklinikum Graz; Abteilung für Hämatologie, Graz

Unknown

ZNA, Antwerp

UZ Leuven, Leuven

Laiko General Hospital, Athens

Princess Margaret Hospital, Hong Kong

Prince of Wales Hospital, Hong Kong

Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia, Nyíregyháza

Wolfson Medical Center, Holon

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna, Ferrara

Azienda Ospedaliera Universitaria Careggi, Florence

"IRCCS Istituto Romagnolo per lo studio dei tumori Dino Amadori", Meldola

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

Azienda Ospedaliera San Gerardo di Monza, Monza

AOU S.Luigi Gonzaga, Orbassano

Ospedale Sant'Eugenio, Rome

Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi, Varese

Pratia Onkologia Katowice, Katowice

Gyeongsang National University Hospital, Jinju

Inje University Busan Paik Hospital, Busan

Daegu Catholic University Medical Center, Daegu

The Catholic University Of Korea St. Vincent Hospital, Gyeonggi-do

Gachon University Gil Medical Center, Incheon

Korea University Anam Hospital, Seoul

Seoul National University Hospital, Seoul

The Catholic University of Korea, Seoul

The Catholic University of South Korea Seoul St. Mary's Hospital, Seoul

Ulsan University Hospital, Ulsan

Hospital Clinic de Barcelona, Barcelona

Vall d'Hebron Institute of Oncology, Barcelona

Hospital Virgen Macarena, Seville

Chang Gung Memorial Hospital Chiayi, Chiayi City

China Medical University Hospital, Chiayi City

Taichung Veterans General Hospital, Taichung

National Taiwan University Hospital, Taipei

Ankara University Faculty of Medicine Cebeci Research and Application Hospital, Ankara

Dr. Abdurrahman Yurtaslan Oncology Health Application and Research Center, Ankara

Antalya Medstar Hospital, Antalya

Edirne Trakya University Faculty of Medicine Hospital, Edirne

Gaziantep University Sahinbey Research and Application Center Hospital, Gaziantep

Izmir Ege University Faculty of Medicine Hospital, Izmir

Kocaeli University Application, Kocaeli

Mersin University, Mersin

Samsun 19 Mayıs University Health Application Research Hospital, Samsun

University College London Hospitals, London

Oxford University Hospitals NHS Foundation Trust, Department of Haematology, Cancer and Haematology Centre, Churchill Hospital, Oxford

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 2B7

University of Alberta Hospital, Edmonton

N6A 5W9

London Health Sciences Center - Victoria Hospital, London

M5G 2M9

Princess Margaret Cancer Center, Toronto

H3T 1E2

Jewish General Hospital, Montreal

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

779 00

University Hospital Olomouc, Olomouc

06202

Hôpital l'Archet 1, Nice

06120

Universitätsklinikum Halle (Saale), Krukenberg-Krebszentrum Halle (KKH), Halle

07747

Universitätsklinikum Jena, Klinik für Innere Medizin II, Jena

455 00

UGH of Ioannina, Ioannina

05460

Hospital Sultanah Bahiyah, Alor Star

6229 HX

Maastricht University Medical Center, Maastricht

21-50

Wojewódzki Szpital Specjalistyczny w Bialej Podlaskiej, Biała Podlaska

80-293

Uniwersyteckie Centrum Kliniczne, Gdansk

60-185

Centrum Medyczne Pratia, Skorzewo

87-100

Nasz Lekarz Przychodnie Medyczne, Torun

03722

Severance Hospital, Yonsei University Health System, Seoul

135-710

Samsung Medical Center, Seoul

EH4 2XU

Western General Hospital, Edinburgh

CF14 4XW

University Hospital of Wales, Cardiff

PE21 9QS

Pilgrim Hospital, Boston

CB2 0QQ

Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge

L7 8YA

The Clatterbridge Cancer Centre, Liverpool

SE1 9RT

Guy's & St Thomas NHS Foundation Trust, London

W12 0HS

Imperial College Healthcare NHS Trust, Hammersmith Hospital, London

Sponsors
All Listed Sponsors
lead

Constellation Pharmaceuticals

INDUSTRY

NCT04603495 - Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) | Biotech Hunter | Biotech Hunter